Status:
ENROLLING_BY_INVITATION
Defining the Skin and Blood Biomarkers of Ichthyosis
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
Icahn School of Medicine at Mount Sinai
Galderma R&D
Conditions:
Ichthyosis
Netherton Syndrome
Eligibility:
All Genders
1-60 years
Brief Summary
Ichthyosis is a group of genetic skin disorders that present with dry, thickened, scaly, or flaky skin. As of today, there is no cure or treatment. Doctors can only treat the dry skin with different t...
Detailed Description
Objectives: 1. To define a panel of skin and blood biomarkers associated with disease activity and pruritus in Netherton syndrome, lamellar ichthyosis, and other ichthyosis subtypes. 2. To determine ...
Eligibility Criteria
Inclusion
- Control and ichthyosis subjects may be of either sex and must be between 1-60 years of age at the time of enrollment
- Ichthyosis subjects include individuals with a diagnosis Netherton syndrome, lamellar ichthyosis, or other ichthyosis subtypes
- Ichthyosis subjects should not have administered systemic immunosuppressant therapy in the month before the study
- Ichthyosis subjects should not use topical immunosuppressants in the week before the study
- Ichthyosis subjects should not have applied emollients to the planned biopsy sites within 12 hours before biopsy, but can be applied elsewhere
- Controls may have no inflammatory disease, atopy, or obvious xerosis (urticaria, food allergy, allergic rhinitis or conjunctivitis, asthma)
- Controls for skin sampling may have no observable abnormality in the sampled skin and, to further assure the normality of the "normal" skin edges, must not have evidence of inflammation or epidermal change in the lesion to be surgically removed
- Subjects and guardians of minors must sign the approved IRB consent form(s) prior to initiation of the study protocol
Exclusion
- Subjects who are unable to give informed consent or assent
- Subjects who administered anti-inflammatory systemic and topical therapy or emollients that do not comply with inclusion criteria prior to blood and biopsy sampling
- Subjects whose main diagnosis is deemed unsafe by the study investigator for study participation
Key Trial Info
Start Date :
January 31 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03417856
Start Date
January 31 2018
End Date
December 31 2025
Last Update
April 24 2025
Active Locations (4)
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1
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
2
Northbrook Lurie Children's Outpatient Clinic
Chicago, Illinois, United States, 60611
3
Northwestern University
Chicago, Illinois, United States, 60611
4
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029